Pharmacokinetics of Imeglimin in Hepatic Impaired Subjects

NCT ID: NCT03802786

Last Updated: 2020-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-06
• Study Completion Date: 2019-07-08

Brief Summary

This is a Phase 1, single-centre, open-label, parallel-group study in subjects with moderate hepatic impairment and subjects with normal hepatic function. Child-Pugh (CP) scoring will be used to determine hepatic impairment.

Conditions

Hepatic Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Moderate hepatic impairment

Single dose of Imeglimin

Group Type: EXPERIMENTAL

Imeglimin

Intervention Type: DRUG

Single administration dose of imeglimin

Normal hepatic function

Single dose of Imeglimin

Group Type: EXPERIMENTAL

Imeglimin

Intervention Type: DRUG

Single administration dose of imeglimin

Interventions

Imeglimin

Single administration dose of imeglimin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Caucasian
• BMI :18.0 and 40.0 kg/m2 and weight ≥50 kg.
• Stable hepatic impairment or normal hepatic function for healthy volunteer
• No clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (Subjects with moderate hepatic impairment may have medical findings consistent with their hepatic dysfunction)
• Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception
• Informed consent signature

Exclusion Criteria

• Clinically relevant abnormal findings at the screening assessment
• Severe adverse reaction to any drug or sensitivity to the trial medication or its componentsClinically significant vital signs outside the acceptable range at screening
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
• Drug or alcohol abuse
• Positive test HIV
• Smoking more than 10 cig/day
• Participation in other clinical trials of unlicensed or prescription medicines

• Positive test for HBV, HBC
• eGFR less than 90 mL/min/1.73 m2
• liver diseases

• eGFR less than 80 mL/min/1.73 m2
• Hepatic impairment due to non liver disease
• History of hepatocellular carcinoma or acute liver disease
• CLinically significant change in liver disease status within 6 months
• ascites
• encephalopathy grade III or IV

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Poxel SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clémence Chevalier

Role: STUDY_DIRECTOR

Poxel SA

Locations

Apex

Munich, , Germany

Countries

Germany

Other Identifiers

PXL008-024

Identifier Type: -

Identifier Source: org_study_id